Job Description

Staff Specialist Regulatory Affairs

As Staff Specialist Regulatory Affairs, you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of product clearances and maintain the highest quality standards. Candidates will be expected to work on-site 4 days per week in our San Diego, CA office.

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Primary Responsibilities:

• Develop and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents.
• Provide regulatory input during the design and development of SaMD, ensuring compliance with applicable standards (e.g., IEC 62304, ISO 14971).
• Assess Cloud based multifunction SaMD products to determine compliance with FDA's guidance on device versus non-device functionality.
• Prepare, submit, and manage regulatory submissions for SaMD products.
• Evaluate the impact of changes to SaMD functionality and determine whether submissions or notifications are required.
• Ensure SaMD compliance with FDA guidance on Clinical Decision Support (CDS) software and other regulatory frameworks.
• Work cross functionally in risk assessments and Design Reviews for SaMD products, including evaluation of cybersecurity risks.
• Collaborate with R&D, Quality, Marketing, and Regulatory teams to ensure regulatory requirements are met throughout the product lifecycle.
• Evaluate software architectural design and identify SaMD functionality.
• Provide training and guidance to cross-functional teams on FDA guidance for SaMD and multifunction device products.

About You:

• Minimum bachelor's degree in engineering, Life Sciences, or a related field.
• 3-5 years of practical experience in regulatory affairs, with a focus on SaMD.
• Comprehensive understanding of FDA regulations and guidance documents related to SaMD, including; 21st Century Cures Act, 21 CFR Part 820, Multifunction Device Products Guidance, Clinical Decision Support Software Guidance and SaMD related Guidance.
• Knowledge of international regulatory requirements (e.g., FDA QSR, ISO 13485, IEC 62304).
• Strong knowledge of risk management processes (ISO 14971) and cybersecurity considerations for medical devices.
• Exceptional analytical and problem-solving skills.
• Excellent written and verbal communication skills, including regulatory writing.
• Strong attention to detail and organizational skills.
• Ability to work collaboratively in cross-functional teams.
• Proficiency with regulatory databases, document control systems, and project management tools.

Preferred Qualifications:

• Certification in regulatory affairs (e.g., RAC).
• Experience with cloud-based, or multifunction software systems.
• Familiarity with post-market surveillance requirements for SaMD.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

$121,100.00 - $199,800.00 USD

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Required Skills

Optional Skills

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Primary Work Location: USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associatestheir well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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